Data Showed Faster Onset with SYMBICORT with Improved Lung Function within
3 and 15 Minutes
WILMINGTON, Del., March 18 /PRNewswire-FirstCall/ -- Data from a new
study demonstrated that the combination asthma maintenance therapy,
SYMBICORT(R) (budesonide/formoterol fumarate dihydrate), provided greater
and faster bronchodilatory effects, or opening of the airways, compared
with Advair (fluticasone propionate/salmeterol) in adults with mild to
moderate asthma. In addition, these data demonstrated that SYMBICORT
provided a similar bronchodilatory response to albuterol. Bronchodilatory
response is defined as the mean time to achieve improvement in lung
function. The results from the two studies were presented at the American
Academy of Allergy, Asthma & Immunology Annual Meeting held in
Philadelphia, March 14-18, 2008.
"SYMBICORT is a combination of two proven asthma medications -
budesonide and formoterol. It reduces inflammation experienced on a chronic
basis to help patients breathe easier and offers fast action, dose after
dose, for bronchodilation (or opening of the lungs)," said lead
investigator Frank C. Hampel, Jr., MD, Central Texas Health Research, New
Braunfels, Texas.
In both studies, bronchodilatory response was measured by the mean
improvements in forced expiratory volume in one second (FEV1) - how much
air a person can exhale during a forced breath in the first second of
exhalation, which is a measure of airway function and can be reduced with
airway obstruction. Assessments were made at multiple time points over 12
hours including those at three minutes and 15 minutes after the medication
was taken.
"SYMBICORT works quickly to improve airflow within 15 minutes, helping
patients to breathe better throughout the day and night," said Philip
Silkoff, MD, Medical Science, AstraZeneca. "It's important for patients,
whose doctors have prescribed a daily maintenance medication to control
inflammation, to take their medicine because even though they are
symptom-free, they're not asthma-free. Asthma never goes away."
Study Results (Abstract #859)
Bronchodilatory response rate was investigated in two identically
designed, multicenter, single-dose, four-period crossover studies. The
studies were conducted in 109 patients (SD-039-0732, N=55; SD-039-0733,
N=54) ages 18 years and older with mild to moderate asthma previously
receiving ICS therapy. After a two-week run-in (two inhalations twice-daily
budesonide pressurized metered-dose inhaler (pMDI) 80 micrograms), patients
were randomized into one of four groups to receive once-daily treatment
with two inhalations of SYMBICORT (budesonide/formoterol pMDI) 80/4.5
micrograms, one inhalation of fluticasone propionate/salmeterol dry powder
inhaler (DPI) 250/50 micrograms, two inhalations of albuterol pMDI 90
micrograms or placebo. Each treatment was separated by a 3- to 14-day
washout period.
In both studies, results showed that mean improvements in FEV1 at three
minutes postdose were significantly greater with SYMBICORT and albuterol
pMDI compared to fluticasone propionate/salmeterol DPI (P<.001). At the
same time, all active treatments resulted in significantly greater FEV1 at
three minutes postdose compared to placebo (P less than or equal to .029).
In addition, significantly (P<.001) more patients (combined studies)
achieved greater than or equal to 15 percent and greater than or equal to
12 percent improvements in FEV1 within 15 minutes postdose with SYMBICORT
and albuterol pMDI versus fluticasone propionate/salmeterol DPI. All
treatments were well tolerated.
About SYMBICORT
SYMBICORT is a combination therapy indicated for the long-term
maintenance treatment of asthma in patients 12 years of age and older.
Administered twice daily SYMBICORT is a combination of budesonide, an
inhaled corticosteroid (ICS), and formoterol, a rapid and long-acting
beta2-agonist (LABA). SYMBICORT does not replace fast-acting inhalers and
should not be used to treat acute symptoms of asthma. SYMBICORT has safety
data in long-term studies of up to one year, and has a robust cardiac
safety profile.
Important Safety Information
Long acting beta2-adrenergic agonists may increase the risk of asthma-
related death. Therefore, when treating patients with asthma, SYMBICORT
should only be used for patients not adequately controlled on other
asthma-controller medications (e.g., low-to-medium dose inhaled
corticosteroids) or whose disease severity clearly warrants initiation of
treatment with two maintenance therapies. Data from a large
placebo-controlled U.S. study compared the safety of another long-acting
beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma
therapy showed an increase in asthma-related deaths in patients receiving
salmeterol. This finding with salmeterol may apply to formoterol (a
long-acting beta2-adrenergic agonist), one of the active ingredients in
SYMBICORT.
SYMBICORT is not indicated for the relief of acute bronchospasm.
SYMBICORT should not be initiated in patients during rapidly
deteriorating or potentially life-threatening episodes of asthma.
Particular care is needed for patients who are transferred from
systemically active corticosteroids. Deaths due to adrenal insufficiency
have occurred in asthmatic patients during and after transfer from systemic
corticosteroids to less systemically available inhaled corticosteroids.
Patients who are receiving SYMBICORT twice daily should not use
additional formoterol or other long-acting inhaled beta2-agonists for any
reason.
Common adverse events reported in clinical trials, occurring in greater
than or equal to 5 percent of patients, regardless of relationship to
treatment, including nasopharyngitis, headache, upper respiratory tract
infection, pharyngolaryngeal pain, sinusitis, and stomach discomfort.
Please see full Prescribing Information and visit
http://www.MySYMBICORT.com
About AstraZeneca
AstraZeneca (NYSE: AZN) is a major international healthcare business
engaged in the research, development, manufacturing and marketing of
meaningful prescription medicines and supplier for healthcare services.
AstraZeneca is one of the world's leading pharmaceutical companies with
healthcare sales of $29.55 billion and is a leader in gastrointestinal,
cardiovascular, neuroscience, respiratory, oncology and infectious disease
medicines. In the United States, AstraZeneca is a $13.35 billion dollar
healthcare business with 12,200 employees committed to improving people's
lives. AstraZeneca is listed in the Dow Jones Sustainability Index (Global)
as well as the FTSE4Good Index.
For more information visit http://www.astrazeneca-us.com.
SOURCE AstraZeneca
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Related links:
http://www.astrazeneca-us.com
http://www.MySYMBICORT.com
http://www.prnewswire.com/comp/985887.html/
CONTACT:
Michele Meeker, +1-302-885-6351,
michele.meeker@astrazeneca.com, or Katie Neff, +1-302-885-9960,
katie.neff@astrazeneca.com, both of AstraZeneca
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